A Tale of Two IOM Committees

Today the Institute of Medicine (IOM) published the report titled, “Chronic Multisymptom Illness in Gulf War Veterans: Case Definitions Reexamined”.

Given that the IOM has been engaged in a project regarding ME/CFS, we felt it would be useful to compare the two studies.

The committee that authored this report titled, “Chronic Multisymptom Illness in Gulf War Veterans” was formed in early 2013 and concluded their work in December of that same year. The Veterans Administration charge to this IOM committee was to “comprehensively review, evaluate, and summarize the available scientific and medical literature regarding symptoms for CMI among the 1991 Gulf War Veterans” in order to:

Develop a research case definition and if possible, a clinical case definition for CMI (chronic multisymptom illness) as it pertains to the 1990-91 Gulf War veteran population and;

Evaluate the terminology currently used in referring to CMI in Gulf War veterans and recommend appropriate usage.

Dr. Suzanne D. Vernon, the Association’s Scientific Director, was nominated and volunteered her time to serve on this committee along with Dr. Fred Friedberg, Stony Brook University and President of the IACFSME and 14 of their well-respected peers. See the full committee roster and bio sketches HERE.

After rigorous evaluation and extensive deliberation, the committee made the following recommendations.

1) That the Department of Veteran Affairs consider the use of two existing definitions known as the Centers for Disease Control and Prevention (CDC) definition and the Kansas definition because these capture the most commonly reported symptoms.

It is noteworthy that the committee did not develop a new research or clinical case definition. This is because many of the elements necessary to derive a case definition including onset, duration, severity and objective laboratory findings were lacking in the published literature. Further, the committee did not recommend one definition over the other because both captured the array of the most common symptoms experienced by Gulf War veterans.

2) That the Department of Veteran Affairs assess existing data that could be useful in describing symptom onset, duration, severity, frequency and exclusionary criteria to help with the development of more robust case definition criteria.

This is important because of the gaps in the existing published evidence. It is challenging to develop a case definition if the necessary information to define a disease is not examined, is not available or does not exist. Therefore, review of existing data in ways that could possibly clarify case definition features like duration and symptom severity will help improve future iterations of both the CDC and Kansas definitions.

3) That the Department of Veteran Affairs use Gulf War Illness rather than chronic multisymptom illness to capture the population involved in the 1990-1991 conflict.

Diseases may be named after specific events or geographic locations such as Legionnaires disease or the Spanish flu. The committee acknowledged the unique circumstances of the 1990-1991 Gulf War and the fact that Gulf War Illness has been used extensively in the medical and scientific literature.

Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;

Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;

Recommend whether new terminology for ME/CFS should be adopted;

Develop an outreach strategy to disseminate the definition nationwide to health professionals

While there are similarities in the charges to these two committees, there are differences as well.

The IOM conducts studies by reviewing the published, existing evidence.

In the case of the CMI committee, they only reviewed published evidence.

The ME/CFS committee has asked stakeholders to provide data, some that may be yet unpublished. This is important as it may provide important new evidence for clinical diagnostic criteria.

With the CMI committee there was insufficient evidence to justify the development of a new case definition for Gulf War Illness. Since the ME/CFS committee has access to new existing data and strong case definitions already exist, they may be in a better position regarding evidence-based diagnostic criteria.

Both committees were charged with recommending new terminology.

The CMI committee recommended use of the name Gulf War Illness for the reasons stated above.

In the case of ME/CFS, their terminology recommendation remains to be seen.

The CMI committee was not charged with developing an outreach strategy.

However, the CMI committee recommendations were to the Department of Veterans Affairs; the agency decides how the CDC and Kansas definitions should be used in the research they conduct and fund. Consistent use and reporting of research using these case definitions will help build a robust evidence base to accelerate the discovery of objective biomarkers and treatments for veterans with Gulf War Illness.

The ME/CFS committee is charged with developing an outreach strategy to get the information to health professional nationwide – hoping to meet a deep need in the community for more informed care.

In many of the arguments against the IOM Committee for ME/CFS, detractors have noted failing on the part of the IOM committee responsible for the report “Treatment of Chronic Multisymptom Illness”, this report is not the the one published today (March 12, 2014). The treatment report was based on review of the literature of veterans’ health involved from the 1990-1991 Desert Shield and Storm conflicts to active duty service members currently in the Gulf Region and the evidence for treatment of the chronic illnesses and the many varied medically unexplained symptoms they experience. Perhaps the greatest failing is the dearth of published evidence in the biomedical literature for treating serious diseases like Gulf War Illness.

Currently there is a lack of a widely accepted and recognized disease-defining concepts for the core signs, symptoms and decreasing functionality for ME/CFS. The Canadian Clinical Criteria has merit and at same time has not been widely distributed and uniformly accepted. The development of safe and effective treatments for ME/CFS require uniformly accepted criteria that can be used consistently by researchers, clinicians and patients. One of the reasons for the slow progress has been the lack of reliable clinical diagnostic criteria for ME/CFS, so the work now underway with the IOM ME/CFS committee could be a critical step forward for progress.

The New York Times calls the IOM the United States’ “most esteemed and authoritative adviser on issues of health and medicine, and its reports can transform medical thinking around the world.” Its mission is to serve as adviser to the nation to improve health. The Institute aims to provide unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large.

The Solve ME/CFS Initiative continues to be cautiously optimistic about the IOM and the committee’s ability to have the impact necessary to make the disease-defining concepts of ME/CFS widely understood and available. The credibility and authority of something like the IOM – the health arm of the National Academy of Sciences – is critical to making ME/CFS widely recognized and diagnosed by the nation’s medical community. Something we all hope to see in the very near future.

Could you comment on the differences in the charge to the two IoM committees on requiring expertise in that disease? In the spring of last year, some GWI advocates complained that the GWI IoM committee lacked extensive clinical or even scientific experience in GWI. Whether that is true or not, did the instructions to the IoM committee on ME/CFS differ in the disease expertise the committee was to have when compared to the instructions to the GWI IoM committee?

Leigh Reynolds

The expertise on these committees is diverse and depends on the charge. Since the charge to the IOM CMI committee involved overlapping syndromes, that may explain why many who served were nominated. There were several Gulf War experts on the committee – some have been working on Gulf War for years, some had funding for Gulf War research, some were clinicians treating GW vets.

Per the invitation for nominations for the the IOM ME/CFS committee, they were searching for experts in the scientific, technical, and medical professions to be considered for a study committee on “Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome” for tasks that include the following:
• Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients;
• Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;
• Recommend whether new terminology for ME/CFS should be adopted;
• Develop an outreach strategy to disseminate the definition nationwide to health professionals.

Experts were sought for the committee in the fields of epidemiology; clinical medicine/primary care; and other health care fields particularly with expertise in ME/CFS including neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology, pediatrics, and scientists and physicians with experience in developing clinical case definitions. And as we know from the committee’s roster, several ME/CFS experts were asked to serve and accepted.

Apparently, Kenneth Shine, former president of the
Institute of Medicine (IOM) and chair of the IOM
committee, that was tasked by the VA with the
development of a case definition for Gulf War Illness (in
its study “Chronic Multisymptom Illness [CMI] in Gulf
War Veterans: Case Definitions Reexamined” released
today), had a gut feeling about the outcome of the
study

Well, at the price tag of $850,000, the IOM was “unable
to develop a new consensus definition of CMI given the
lack of uniform symptoms, the variety of symptoms, and
the long onset and duration,” (http://bit.ly/1i7Lij8)
according to its official report published today.
.
That’s a big taxpayer “oops,” wouldn’t you say?

“The VA [had] asked IOM to develop a case definition
for CMI as it pertains to the veteran population who
served during the 1990-1991 Gulf War, as well as
recommend appropriate terminology for referring to
CMI.”

The IOM simply couldn’t do it. In its report, it basically
admitted to not having the required expertise.

Now, is everybody convinced about the IOM’s lack of
expertise to define ME/CFS?

A literature review by a majority of non-experts is as a
flawed a process as one can imagine for the definition
of an overwhelmingly complex disease, such as ME/CFS.

It cannot be done competently.

The latest IOM report makes it a point in a number of
places to compare the complexity of GWI with that of
ME/CFS.

Expecting a different result from the IOM in the case of

ME/CFS is the stuff Harry Potter books are made of (no
offense to R. K. Rowling). The only difference will be
that the taxpayer bill, at $1million, will be even higher.

Jim Binns, chair of the Research Advisory Committee on
Gulf War Veterans’ Illnesses, a FACA committee, like
CFSAC, commented:

Definitions are not diseases, they are often
simply the best descriptions that physicians and
researchers can offer, with their always
imperfect knowledge, to describe a disease.

Good definitions are good because they
correspond closely to the disease state being
described.

It is thus important that those that attempt
to define any disease or illness … have long
term clinical experience with patients with
this illness.

There is simply no place for the bureaucrat in
defining illness.

All definition of epidemic or infectious illness must
be based upon persistent clinical examination of
the afflicted patient, an understanding and
exploration of the environmental factors
producing that illness, and pathophysiological
examination of tissue from those patients.

For similar reasons, I believe that the inclusion of
psychiatrists in the defining of an epidemic and
obviously disease of infectious origin, simply
muddies the water for any serious understanding
of that disease. (emphasis added)

It takes expert clinicians to define ME/CFS. The IOM
ME/CFS committee consisting of a majority of
non-experts does not have the required expertise, just
like the IOM GWI committee didn’t.

The emperor just doesn’t have any clothes, plain
and simple.

I have not reviewed the report in detail, but one thing
that struck me on a cursory review was that the report
seemed quite repetitive and, one might say, without
even an overlay of the kind professionalism that one
would expect from an institution that is being touted by
HHS as one with utmost credibility.

Speaking of credibility, Simon Wessely, arguably the
most controversial figure in medicine and science of our
time, reviewed the latest IOM report.

Studies that Wessely co-authored are also cited on
numerous occasions, so he basically reviewed and
signed off on his own “research.”

Even if Wessely were right with his psychobabble and
pseudo science – and we all know he is not – I cannot
imagine what could have possibly gone on in the minds
of those who chose him as a reviewer.

By doing so and allowing his name on the report, the
IOM lost all credibility, whether it be due to indifference
to the tremendous controversy surrounding Wessely or
due to the lack of due diligence, i.e., ignorance of the
controversy.

HHS, can you hear us now?

~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:~:
PEM, NOT Chronic Fatigue, is why patients
are bedridden, homebound, unemployed,
and unable to walk a block.
~:~:~:~:~:~:~:~:~:~:~:~:~

gina bettor

Excellent recap. Thank you. I don’t think HHS wants to hear us. They have wasted decades stonewalling. They have their dirty laundry being aired now more than ever with the resignation of the head of research integrity unable to acquire approval for $35 to transfer cassette to CD….. Seriously Dr Koh, shame on you. I invite you to live one week with me and the horrible, neglected disease I live with. Secret lists for political positions, instead of researchers requests… We would be better off having the Rotary clubs take us under their leadership. The turnover rate for CFSAC prevents long term, skilled experts achieving results for their repetitive recommended requests. Their energy is wasted as patients are dying. Is it Secretary Sebellious, or Dr Howard Koh preventing any real progress as we continue to lack funding and validation and HHS “team members” are told to expect less. What should the patients expect? The bar has been set so low. Secret contacts and politics. We need funding and science. We have a definition. We need our government to stop the delays and try some integrity!

Justin Reilly

A top GWI expert called the IoM report “a slanted view of Gulf War research totally inconsistent with the science of the past decade.” (see link below)

The IoM allows committee members to write dissents, which are published in the report. Dr. Vernon’s failure to dissent on all the misinformation on GWI and ME in the report speaks volumes about her and CAA’s motivations.